Chronic Bronchitis/BronchiectasisNCT01718067
Efficacy of Vakum Technology in Patients With Chronic Hypersecretion
A study testing VAKÜM system and conventional manual ELTGOL technique in people with Chronic Bronchitis/Bronchiectasis and Chronic Obstructive Pulmonary Disease, run by Villa Pineta Hospital at 1 site in Italy.
Trial summary
Mechanical devices to increase the individual's bronchial hygiene are commonly used to assist patients with chronic retention of secretions. VAKÜM technology has been recently developed with the aim to improve the respiratory condition in hypersecretive patients suffering from chronic respiratory diseases. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Bronchitis/Bronchiectasis, Chronic Obstructive Pulmonary Disease
- What is being tested?
- VAKÜM system and conventional manual ELTGOL technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with chronic respiratory diseases
- hypersecretion condition(sputum production >30 mL/die)
- reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min- 1)
- patients admitted to standard pulmonary rehabilitation
Who cannot join
- not able to use the device
- concomitant cardiovascular or neoplastic diseases
- utilization of Non Invasive Ventilation
Trial locations and contacts
1 site in 1 country.
Enrico M Clini, Prof. contact
Italy1 site, 1 recruiting
- Recruiting
Villa Pineta Hospital
Modena
Enrico M Clini, Prof.
About this study
Official title: Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.
Mechanical devices to increase the individual's bronchial hygiene are commonly used to assist patients with chronic retention of secretions. VAKÜM technology has been recently developed with the aim to improve the respiratory condition in hypersecretive patients suffering from chronic respiratory diseases.
The aim of this study is to assess the clinical efficacy of VAKÜM technology in patients with hypersecretion, and chronic respiratory diseases a clinical trial has been designed.
Read more
Patients with chronic respiratory diseases, hypersecretion (sputum production >30 mL/die), and reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min-1) referred to standard pulmonary rehabilitation (PR) will be included. Study design is a single-blind multicentre randomized trial with consecutive recruitment. Following a preliminary run-in period, group comparison will be made between Intervention group using VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique, and Control group using manual ELTGOL alone over 10 daily sessions.
Spirometric lung volumes, respiratory muscle strength, arterial blood gases, and quality of life will be recorded in both groups pre-to-post PR. Perceived dyspnea (by VAS scale), sputum volume and characteristics (on a semi-quantitative 3-point scale) and peak expiratory air flows (PEF and PCEF) will be registered on a daily basis over the study period. Primary outcome is the change in perceived dyspnea; in order to ensure 80% power to detect a 5 point (SD 5) group difference change in the primary outcome at the end of the study period as significant at the 0.05 level, at least 42 patients per group are needed. The minimum target sample size will be then fixed at 50 patients per group.
An higher and faster significant reduction of the perceived dyspnea is supposed in the Intervention group. Additional benefits among the secondary outcomes are also hypothesised in the same group.
- Being tested
- VAKÜM system, conventional manual ELTGOL technique
- Keywords
- Chest physiotherapy, Rehabilitation, Chronic respiratory diseases
- Medical subject headings
- Bronchitis, Chronic, Bronchiectasis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAKÜM systemDevice
Also called Free Aspire, MPR, Legnano-I
15 minutes, twice a day.
conventional manual ELTGOL techniqueOther
20 minutes twice a day
| Study group | Role | What they receive |
|---|---|---|
| Vakum | Experimental | VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique Receives: Device: VAKÜM system; Other: conventional manual ELTGOL technique |
| Control | Active comparator | conventional manual ELTGOL technique Receives: Other: conventional manual ELTGOL technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived dyspnea
Visual Analogic Scale (VAS)
Measured: Baseline and 10 days
Secondary outcomes (6)
Change in peak expiratory air flows
Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF)
Measured: Baseline and 10 days
Change in arterial blood gases exchanges
PaO2, PaCO2, SatO2, pH
Measured: Baseline and 10 days
Change in spirometric lung volumes
Static and dynamic lung volumes
Measured: Baseline and 10 days
Change in respiratory muscle strength
Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP)
Measured: Baseline and 10 days
Change in sputum volume and characteristics
Volume, Density (D) and Purulence (P) (D and P assessed on a semi-quantitative 3-point scale)
Measured: Daily over 10 days
Change in quality of life
Quality of life questionnaires (CAT, MRF 28)
Measured: Baseline and 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Bronchitis/BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Villa Pineta Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Clini Enrico, Villa Pineta Hospital
- Investigators
- Enrico M Clini, MD, Principal investigator, University of Modena Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718067
- Sponsor's protocol ID
- 2793
- Status last verified
- Dec 2014
- First submitted
- 22 Oct 2012
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.
- ClinicalTrials.gov ID
- NCT01718067
- Acronym / sponsor ID
- 2793
- Keywords
- Chest physiotherapy, Rehabilitation, Chronic respiratory diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Villa Pineta HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mechanical devices to increase the individual's bronchial hygiene are commonly used to assist patients with chronic retention of secretions. VAKÜM technology has been recently developed with the aim to improve the respiratory condition in hypersecretive patients suffering from chronic respiratory diseases.
The aim of this study is to assess the clinical efficacy of VAKÜM technology in patients with hypersecretion, and chronic respiratory diseases a clinical trial has been designed.
Patients with chronic respiratory diseases, hypersecretion (sputum production >30 mL/die), and reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min-1) referred to standard pulmonary rehabilitation (PR) will be included. Study design is a single-blind multicentre randomized trial with consecutive recruitment. Following a preliminary run-in period, group comparison will be made between Intervention group using VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique, and Control group using manual ELTGOL alone over 10 daily sessions.
Spirometric lung volumes, respiratory muscle strength, arterial blood gases, and quality of life will be recorded in both groups pre-to-post PR. Perceived dyspnea (by VAS scale), sputum volume and characteristics (on a semi-quantitative 3-point scale) and peak expiratory air flows (PEF and PCEF) will be registered on a daily basis over the study period. Primary outcome is the change in perceived dyspnea; in order to ensure 80% power to detect a 5 point (SD 5) group difference change in the primary outcome at the end of the study period as significant at the 0.05 level, at least 42 patients per group are needed. The minimum target sample size will be then fixed at 50 patients per group.
An higher and faster significant reduction of the perceived dyspnea is supposed in the Intervention group. Additional benefits among the secondary outcomes are also hypothesised in the same group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vakum | Experimental | Device: VAKÜM system, Other: conventional manual ELTGOL techniqueVAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique |
| Control | Active comparator | Other: conventional manual ELTGOL techniqueconventional manual ELTGOL technique |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with chronic respiratory diseases
- hypersecretion condition(sputum production >30 mL/die)
- reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min- 1)
- patients admitted to standard pulmonary rehabilitation
Key exclusion criteria (3 listed)
- not able to use the device
- concomitant cardiovascular or neoplastic diseases
- utilization of Non Invasive Ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAKÜM systemAlso: Free Aspire, MPR, Legnano-I15 minutes, twice a day. | Device | Vakum |
| conventional manual ELTGOL technique20 minutes twice a day | Other | Control, Vakum |
Primary outcome
Change in perceived dyspnea
Time frame: Baseline and 10 days
Visual Analogic Scale (VAS)
6 secondary outcomes
Change in peak expiratory air flows
Time frame: Baseline and 10 days
Change in arterial blood gases exchanges
Time frame: Baseline and 10 days
Change in spirometric lung volumes
Time frame: Baseline and 10 days
Change in respiratory muscle strength
Time frame: Baseline and 10 days
Change in sputum volume and characteristics
Time frame: Daily over 10 days
Change in quality of life
Time frame: Baseline and 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
Related trials for Chronic Bronchitis/Bronchiectasis
Not yet recruiting
Digital Physiotherapy for Pediatric Chronic Suppurative Lung Diseases
Chronic Suppurative Lung Disease, Protracted Bacterial Bronchitis
RecruitingObservational study
Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath
Lung Cancer, Lung Infection
RecruitingObservational study
COPD Patient-Powered Research Network
Chronic Obstructive Pulmonary Disorder, Chronic Obstructive Lung Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico M Clini, Prof. contact
Enrico M Clini, MD principal investigator
University of Modena Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAKÜM system and conventional manual ELTGOL technique in people with Chronic Bronchitis/Bronchiectasis and Chronic Obstructive Pulmonary Disease, run by Villa Pineta Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrico M Clini, Prof. (enrico.clini@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived dyspnea (time frame: Baseline and 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.